A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy
Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or
Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary

This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of VTX-2337 in combination with cisplatin or carboplatin, 5-Fu and cetuximab in prolonging the progression-free survival in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck.
Subjects will be screened for eligibility and qualified subjects will be randomized 1:1 to 1 of 2 treatment groups:
[?] SoC + VTX-2337
[?] SoC + placebo

Following the screening period, qualified subjects will be randomized in a 1:1 ratio to receive SoC plus placebo or SoC plus VTX-2337. Randomization of all subjects will be stratified by receipt of prior chemotherapy (yes or no), eCoG performance status (0 or 1), and platinum therapy as assigned by the investigator at the time of randomization (cisplatin or carboplatin).

Subjects will then be administered cisplatin or carboplatin-as assigned by the investigator prior to randomization-5-Fu, cetuximab, and iP (i.e., VTX-2337 or placebo) on pre-specified days of a 21-day cycle for 6 cycles ([Section]6.0). Thereafter, subjects will continue on study for cycles 7+ for dosing of weekly cetuximab and biweekly iP in 28-day cycles.

Subjects will be evaluated for PFS according to immune-related Response evaluation Criteria in Solid Tumors (irReCiST; [Section]6.6.1.2) at Week 12 ((+-) 3 days), Week 18 ((+-) 3 days), and every 8 weeks ((+-) 7 days) thereafter. Treatment will be discontinued for subjects with independently-confirmed radiographic disease progression. upon discontinuation of treatment, subjects will complete the end of Treatment visit and will be followed for survival.

VTX-2337 or placebo (investigational product; iP) will be administered as a subcutaneous injection on Day 8 and Day 15 of a 21-day cycle at a dose level of 3.0 mg/m2 for 6 cycles, followed by dosing on Days 8 and 22 of a 28-day cycle for cycles 7 and beyond. iP will be administered until disease progression.